Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)

Phase 1

Recruiting

• Conditions: Solid Tumor Cancer; Locally Advanced; Metastatic Solid Tumors; Lung Cancers; Epithelial Tumor
• Interventions: Drug: AVZO-1418; Drug: Combination Agent 1; Drug: Combination Agent 2

• Registration Number: NCT07038343
• Lead Sponsor: Avenzo Therapeutics, Inc.

Brief Summary

This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a monotherapy and potentially in combination therapy to patients with locally advanced or metastatic epithelial solid tumors.

Detailed Description

This first-in-human, Phase 1/2 study will aim to obtain safety and tolerability data when AVZO-1418 is administered intravenously to patients with locally advanced or metastatic epithelial solid tumors.

Phase 1 is a dose escalation phase which will assess the safety and tolerability of AVZO-1418 and determine the maximum tolerated dose (MTD) and preliminary recommended Phase 2 dose (RP2D) of AVZO-1418 as a monotherapy. This data can guide selection of combination schedules and agents.

Phase 2 is a dose expansion phase that will aim to assess the antitumor activity of AVZO-1418 as a monotherapy and potentially in combination therapy.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study Start: 2025-06-19
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Primary Completion: 2030-06
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1, monotherapy	AVZO-1418	Group A
Phase 1, combination	AVZO-1418	Group B
Phase 1, combination	Combination Agent 1	Group B
Phase 1, combination	Combination Agent 2	Group B
Phase 2, monotherapy	AVZO-1418	Part A
Phase 2, combination	AVZO-1418	Part B
Phase 2, combination	Combination Agent 1	Part B
Phase 2, combination	Combination Agent 2	Part B

Primary Outcome Measures

Name	Time	Method
Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)	Approximately 2 years	Number of participants with DLTs assessed for severity using CTCAE v5.0 criteria will be summarized by dose level.
Determine the maximum tolerated dose (MTD) and/or preliminary recommended Phase 2 dose (RP2D) (Phase 1)	Approximately 16 months
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1)	From baseline until end of study treatment or study completion (approximately 2 years)
Objective Response Rate (ORR) (Phase 2)	From baseline through disease progression or study completion (approximately 2 years)	Defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) (Phase 1)	From baseline through disease progression or study completion (approximately 2 years)
Duration of Response (DOR) (Phase 1 and 2)	From baseline through disease progression or study completion (approximately 2 years)	Defined as the time from the first confirmed response to radiologic/objective progression.
Disease Control Rate (DCR) (Phase 1 and 2)	From baseline through disease progression or study completion (approximately 2 years)	Defined as the proportion of patients who achieve tumor relief (CR or PR) and stable disease (SD) after treatment; calculated as the sum of CR, PR, and SD.
Progression Free Survival (PFS) (Phase 1 and 2)	From baseline through time to event on study or study completion (approximately 2 years)	Defined as the time from study drug treatment to death or disease progression, as determined by the investigator by radiographic disease assessment according to RECIST v1.1.
Overall Survival (OS) (Phase 1 and 2)	Approximately 76 months	Defined as the time from study drug treatment initiation to death from any cause.
PK Parameters: Maximum observed concentration (Cmax) (Phase 1)	Up to 2 years
PK Parameters: Minimum observed concentration (Cmin) (Phase 1)	Up to 2 years
PK Parameters: Time to maximum observed concentration (Tmax) (Phase 1)	Up to 2 years
PK Parameters: Elimination half-life (T1/2) (Phase 1)	Up to 2 years
PK Parameters: Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) (Phase 1)	Up to 2 years
PK Parameters: Area under the concentration-time curve from time 0 to infinity (AUCinf) (Phase 1)	Up to 2 years
PK Parameters: Area under the concentration-time curve from time 0 to the end of the dosing period (AUCτ) (Phase 1)	Up to 2 years
PK Parameters: Apparent Clearance (CL/F) (Phase 1)	Up to 2 years
PK Parameters: Apparent volume of distribution at steady-state (Vss) (Phase 1)	Up to 2 years
PK Parameters: Accumulation ratio (AR) (Phase 1)	Up to 2 years
Determination of RP2D (Phase 2)	Approximately 16 months
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 2)	From baseline until end of study treatment or study completion (approximately 2 years)

Trial Locations

Locations (1)

Avenzo Therapeutics Recruiting Site; 🇺🇸 Fairfax, Virginia, United States